Lipid/Liver Test Panel Gets Waiver

A new combined test panel called Lipid Profile ALT (Cholestech Corp., Hayward, Calif.) has received an FDA waiver from Clinical Laboratory Improvement Amendments (CLIA) standards. The panel, designed for use with the Cholestech LDX System, combines an alanine aminotransferase (ALT) test with a lipid profile, supplying total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride and ALT measurements from a single fingerstick. The Lipid Profile ALT test allows for a point-of-care assessment of elevated cholesterol levels and liver damage while at the same time allowing for medication dosage adjustments and on-the-spot safety monitoring. Introduced in 1988, CLIA established quality standards for laboratory testing to ensure accuracy, reliability and timeliness of results regardless of test site; CLIA waived tests, recognized by the FDA to be so simple to use and accurate that error risk is small, are not subject to the more stringent requirements of moderate- or high-complexity laboratories.